drugset / Trial / NCT03651557
Antioxidant and NMDA Receptor Blocker Wins Anoxic Brain Damage of KorEa OHCA Patients
Phase 2
Unknown
150 enrolled
GNT Pharma
Chonnam National University Hospital · collabGangnam Severance Hospital · collabKyungpook National University Hospital · collabPusan National University Hospital · collabSamsung Medical Center · collabSoonchunhyang University Hospital · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study aims to investigate the efficacy and safety of Neu2000KWL, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.
Timeline
- Start
- 2018-11-29
- Primary completion
- 2021-05
- Completion
- 2021-05
Outcome
Missed primary endpoint
paper There was no difference in serum NSE between high-dose (median and interquartile range; 23.7, 15.0-69.9) and placebo (17.5, 13.6-113.0) groups PMID 39899673 ↗
paper Nelonemdaz treatment of patients after OHCA did not reduce serum NSE levels compared with controls. PMID 39899673 ↗
Publications
- Chun BJ, Yeom SR, Chung SP, Lee YH, Lee J, Kim YH, Lee JS, Lee JS, An CS, Gwag BJ, Choi JH. Nelonemdaz Treatment for Patients With Out-of-Hospital Cardiac Arrest: A Randomized Clinical Trial. Crit Care Med. 2025 Apr 1;53(4):e772-e782. doi: 10.1097/CCM.0000000000006579. Epub 2025 Jan 14.
- Choi JH, Chun BJ, Yeom SR, Chung SP, Lee YH, Kim YH, Lee JS, Lee JH, Lee HG, Jin JY, An CS, Gwag BJ. Rationale and methods of the Antioxidant and NMDA receptor blocker Weans Anoxic brain damage of KorEa OHCA patients (AWAKE) trial. Trials. 2022 Jul 23;23(1):587. doi: 10.1186/s13063-022-06452-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neu2000KWL | Unknown | 500 mg | Other |
| Subject | Neu2000KWL | Unknown | 750 mg | Other |